drugset / Trial / NCT05624112

Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China

NCT05624112

Phase 4 Completed 44 enrolled Sanofi
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping. During the first 2 treatment weeks, patients will have 2 on-site visits/week, followed by one on-site visit/week up to Week 4, one on-site visit every two weeks from Week 4 to Week 8, and one on-site visit every 4 weeks up to Week 16 End of Treatment phase visit (EoT) thereafter. A follow-up visit by phone 4 weeks after the last study assessment at Week 16 will end the study for each participant (End of Study: EoS). The maximum duration of the study per participant will be 24 weeks.

Timeline

Start
2022-11-25
Primary completion
2024-01-25
Completion
2024-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody Subcutaneous

Indications